Abzena PLC
Sr IT Systems Analyst - Lab & Manufacturing Systems
Abzena PLC, San Diego, California, United States, 92189
Overview
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. Role
The Senior IT Systems Analyst Lab & Manufacturing Systems serves as the technical owner and advisor for laboratory computerized systems and supporting IT infrastructure across both GxP and non-GxP environments. This role is responsible for the secure design, implementation, administration, and lifecycle management of systems that support laboratory instrumentation, manufacturing operations, and IT needs. The position ensures reliability, compliance, and business continuity by managing infrastructure, system integrations, data integrity, and user access. Working closely with quality, engineering, vendors, and cross-functional teams, this role plays a critical part in delivering validated and compliant systems that align with corporate and regulatory standards. This role is on-site in the Mira Mesa area of San Diego, CA. Responsibilities Provide ownership of lab and manufacturing computerized systems and IT infrastructure Oversee secure deployment, administration, and scaling of lab systems Support system implementations (such as Cytiva AKTA, Agilent HPLC and Vi-CELL BLU, LIMS, Empower, OpenLab, etc.), integrations, and upgrades across lab and manufacturing environments Maintain system compliance with 21 CFR Part 11 and data integrity standards Manage IT support for onboarding new instruments and platforms Partner with vendors, quality, and engineering teams to deliver compliant solutions Collaborate with Quality on Computer System Validation (CSV) activities and documentation Ensure data backup, recovery, and business continuity strategies are in place Act as escalation point for technical troubleshooting and root cause analysis Collaborate with IT leadership, IT MSP, lab functions, and business teams Support audits and represent IT during internal, customer, and regulatory inspections Perform other duties as assigned
Qualifications
Bachelors degree in computer science, information systems, or related field or 10+ years of IT experience in pharma or related industry Strong knowledge of GMP, FDA guidelines, and 21 CFR Part 11 Demonstrated experience with computer system validation, system lifecycle methodology, and data integrity practices Proven ability to support lab and manufacturing IT systems, including integrations, upgrades, and new instrument onboarding Proficient in ITIL principles, IT security best practices, and risk management Hands-on experience with Windows Server and Active Directory, including domain management, group policies, and workstation/domain integrations Proficiency in network configuration and troubleshooting (TCP/IP, VLANs, firewalls, switches, Wi-Fi, and VPNs) to support lab and manufacturing connectivity Experience with workstation imaging, OS builds, and installation/configuration of server and client applications in regulated environments Hands-on experience with pharmaceutical systems such as Empower CDS, LIMS (Laboratory Information Systems), and Electronic Lab Notebook (ELN) is a plus Excellent problem-solving, communication, and organizational skills with ability to manage multiple priorities Proficient in MS Office and capable of developing documentation, SOPs, and technical training materials
Salary: 120,000 - 160,000 a year FLSA:
Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. #J-18808-Ljbffr
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. Role
The Senior IT Systems Analyst Lab & Manufacturing Systems serves as the technical owner and advisor for laboratory computerized systems and supporting IT infrastructure across both GxP and non-GxP environments. This role is responsible for the secure design, implementation, administration, and lifecycle management of systems that support laboratory instrumentation, manufacturing operations, and IT needs. The position ensures reliability, compliance, and business continuity by managing infrastructure, system integrations, data integrity, and user access. Working closely with quality, engineering, vendors, and cross-functional teams, this role plays a critical part in delivering validated and compliant systems that align with corporate and regulatory standards. This role is on-site in the Mira Mesa area of San Diego, CA. Responsibilities Provide ownership of lab and manufacturing computerized systems and IT infrastructure Oversee secure deployment, administration, and scaling of lab systems Support system implementations (such as Cytiva AKTA, Agilent HPLC and Vi-CELL BLU, LIMS, Empower, OpenLab, etc.), integrations, and upgrades across lab and manufacturing environments Maintain system compliance with 21 CFR Part 11 and data integrity standards Manage IT support for onboarding new instruments and platforms Partner with vendors, quality, and engineering teams to deliver compliant solutions Collaborate with Quality on Computer System Validation (CSV) activities and documentation Ensure data backup, recovery, and business continuity strategies are in place Act as escalation point for technical troubleshooting and root cause analysis Collaborate with IT leadership, IT MSP, lab functions, and business teams Support audits and represent IT during internal, customer, and regulatory inspections Perform other duties as assigned
Qualifications
Bachelors degree in computer science, information systems, or related field or 10+ years of IT experience in pharma or related industry Strong knowledge of GMP, FDA guidelines, and 21 CFR Part 11 Demonstrated experience with computer system validation, system lifecycle methodology, and data integrity practices Proven ability to support lab and manufacturing IT systems, including integrations, upgrades, and new instrument onboarding Proficient in ITIL principles, IT security best practices, and risk management Hands-on experience with Windows Server and Active Directory, including domain management, group policies, and workstation/domain integrations Proficiency in network configuration and troubleshooting (TCP/IP, VLANs, firewalls, switches, Wi-Fi, and VPNs) to support lab and manufacturing connectivity Experience with workstation imaging, OS builds, and installation/configuration of server and client applications in regulated environments Hands-on experience with pharmaceutical systems such as Empower CDS, LIMS (Laboratory Information Systems), and Electronic Lab Notebook (ELN) is a plus Excellent problem-solving, communication, and organizational skills with ability to manage multiple priorities Proficient in MS Office and capable of developing documentation, SOPs, and technical training materials
Salary: 120,000 - 160,000 a year FLSA:
Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. #J-18808-Ljbffr